Agenda
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Coffee
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Enhesa Product service presentation and platform demo
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Welcome and introduction by the moderator
- SESSION 4: Best practices for managing the BPR
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How to avoid pitfalls with mutual recognition and same biocidal products application
- Supporting the authorisations granted under transitional period by available mutual recognition (MR) and same biocidal products (SBP) procedures
- MR procedures strategies - how to choose a procedure and when to apply
- SBP and possible challenges
Karolina PastuszkoChief Specialist, The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products -
Key learnings for biocidal product family (BPF) in the Union Authorisation (UA) procedure
- Pre-submission considerations
- BPF best practices
- First experiences with QUAT families
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Best practice for creating labels
- Challenges and best practices preparing a biocidal product label
- Current status of misleading trade name discussion and how to prepare for upcoming changes
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Q&A
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Refreshment break and networking
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Best practice on where to find relevant guidance
- Finding relevant documents for an application – from regulatory to technical and supporting aspects
- Prioritise the document verification
- Latest updates on documents published by authorities
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An overview of dossier requirements for in situ-generated biocidal products
- Guidance and developments
- Transitional vs BPR
- Active substances vs product authorisation
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Q&A
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Lunch and Networking
- SESSION 5: The latest testing and modelling updates
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Why - and how - to assess biocides in relation to drinking water treatment processes
- Joint guidance for PPP and biocides?
- Transformation of active substances in drinking water treatment
- Key steps
Ursula KargesSenior Researcher Water Resources Management/Head of Resource Protection Subdivision, IWW Water Centre -
Substances of concern in biocidal product families (BPF): Case studies
- What is a substance of concern (SoC)
- Case studies
- SoCs in a biocidal product family: what is affected?
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'To bee or not to bee, that is the question!' New guidance on risk assessment for bees - impact on PT18 biocides
- Comparison between old and new requirements for the impact and assessment of bees and other arthropods
- How the guidance is heading towards the ‘one substance one assessment’ approach across regulatory frameworks
- The impact of the new guidance on PT18 and future prospects for other product types
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Q&A
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Refreshment break and networking
- SESSION 6: Important efficacy considerations
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The latest developments in chlorine efficacy testing for swimming pool disinfection
- Approach to the efficacy testing when no BPR guidance/standard tests are available
- Practical case of chlorine disinfectants for swimming pools, whirlpools and spas
Darja DuhEfficacy Assessor of Active Substances and Biocidal Products, Chemicals Office of the Republic of Slovenia (CORS) -
Efficacy data, from primitive to primordial
- How efficacy data influences many other aspects of a BPR product dossier
- How to stay abreast of critical developments related to efficacy testing
- How to increase acceptance of efficacy test results
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Q&A
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Close of conference